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Completed

NCT Number: NCT01503658

Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel

This study has an open-label, five-period, single-sequence design. The purpose of this study is as follows;

1. Primary

* To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of clopidogrel 2. Secondary

* To explore the representative biomarkers for the variable pharmacokinetics/pharmacodynamics of clopidogrel * To evaluate the influence of genotype of drug metabolizing enzyme or transporter on the drug-drug interactions between aspirin and clopidogrel * To explore the representative biomarkers for the drug-drug interactions between aspirin and clopidogrel

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Healthy male subjects aged 20 - 45 years.
  • 2. A body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive).
  • 3. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.

Exclusion criteria

  • 1. Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel or aspirin)
  • 2. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
  • 3. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
  • 4. A subject whose lab test results are as follows; Platelet count or PT, aPTT < 0.9 x lower limit of reference range of > 1.1 x upper limit of reference range.
  • 5. A subject whose SBP is over 160 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
  • 6. Presence or history of drug abuse or positive result in urine drug screening test.
  • 7. Participation in other clinical trial within 2 months before first dose.
  • 8. Use of CYP inducer (ex. rifampin) within 4 weeks before first dose.
  • 9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose.
  • 10.Use of grapefruit juice within 1 week before first dose.
  • 11. Blood donation during 2 months or apheresis during 1 month before the study.
  • 12. Use of alcohol over 21 units/weeks
  • 13. Smoking of more than 10 cigarettes/days within 3 months before first dose.
  • 14. Subject judged not eligible for study participation by investigator.

Treatment and study plan

Clopidogrel+aspirin

Drug

Clopidogrel 75 mg, Aspirin 100 mg

Primary outcomes

  1. Pharmacokinetics of Clopidogrel

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h postdose on Day 1, Day 15 and Day 29

    Plasma concentration of clopidogrel and active metabolite of clopidogrel

  2. Pharmacodynamics of clopidogrel

    Time frame: Predose and 4, 24 h postdose on Day 1, Day 15 and Day 29

    Relative inhibition of platelet aggregation by aggregometer or VerifyNow

Secondary outcomes

  1. mRNA/microRNA/endogenous metabolite

    Time frame: predose on Day 1, Day 8, Day 15, Day 22 and Day 29

    mRNA of PON1 and CYP2C19, CYP3A5, MDR1 microRNA endogenous metabolite

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Clinical Trial to Evaluate the Influence of Genotype of Drug Metabolizing Enzyme or Transporter and Drug-drug Interactions on the Pharmacokinetics/Pharmacodynamics of Clopidogrel in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 4, 2012
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.